2010-12-08-世界卫生组织-INN_51st_Executive_Summary_8页_123kb

51st INN Consultation Summary (Geneva, 2010)

Program Overview

• Objective: Discuss International Nonproprietary Names (INNs) for pharmaceutical substances.
• Participants: INN Expert Group, WHO representatives, regulatory agencies, and stakeholders.
• Key Areas: Name selection, nomenclature standards, mechanism of action definitions, composite substances.

Nomenclature Highlights

• INN Requests:
  • 82 new INN requests (28 biologicals), 23 outstanding, 8 previously proposed names.
  • 95 new names selected; 5 deferred; 4 rejected for non-compliance; 7 amendments planned.
• Mechanism of Action (A&U Statements):
  • Clarified definitions for complex substances (e.g., racemic mixtures, enantiomers).
  • Preferred expressions adapted for better clinical relevance.
• Stem Definitions:
  • 63 stem definitions reviewed, 2 amended to enhance descriptive accuracy.

Stakeholder Updates

Collaborators

• IUPAC: Updating chemical nomenclature guidelines, including integration of INNs.
• PMDA: 46 INN-related applications in 2010, maintaining alignment with INN stems.
• USAN Program: 56 applications forwarded to INN; database completed for historical names.
• FDA: New regulations may impact existing name definitions and established nomenclature.
• USP: Forming advisory group for salt drug substance naming policy (2013 implementation).
• EU Commission (TAXUD): Finalized 4th pharmaceutical arrangement with INNs for duty-free treatment in trade.
• EDQM: Providing European-language INN names for regulatory use.

Challenges and Discrepancies

• Stakeholder open session addressed naming issues for:
  • Modified gemcitabine (Clavis Pharma): Request for one-word INN to avoid confusion.
  • Gastrin antagonist (Hammersmith Medicines): Alternative name sought due to stem incompatibility.
  • Glucuronoxylan sulfate (Parnell Technologies): Structural differences from analogous compounds.

System Enhancements

• IDMIS: Upgraded for post-meeting comments; imminent online application system deployment.
• WIPO Collaboration: Joint efforts to improve public database accessibility for trademark examinations.

Concluding Notes

• Next Meeting: 52nd INN Consultation (Geneva, April 12-14, 2011).
• Focus: Standardization of INN selection for biologicals, composite substances, and proactive training in emerging economies.